Phase 3 N=362 Randomized Quadruple-blind Treatment

Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Lateral Canthal Lines) in Subjects With Moderate to Severe Upper Facial Lines

Moderate to Severe Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)

Bottom Line

View on ClinicalTrials.gov: NCT04594213 ↗

Enrolled (actual)

362

Serious AEs

0.8%

Results posted

May 2024

Primary outcome: Primary: Main Period: Percentage of Glabellar Frown Line (GFL) Responders at Day 30 — 0; 52.3 percentage of subjects — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: NT 201 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merz North America, Inc.
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Main Period: Percentage of Glabellar Frown Line (GFL) Responders at Day 30	0; 52.3	<0.0001 sig
PRIMARY Main Period: Percentage of Horizontal Forehead Lines (HFL) Responders at Day 30	0; 66.5	<0.0001 sig
PRIMARY Main Period: Percentage of Lateral Canthal Lines (LCL) Responders at Day 30	0; 51.7	<0.0001 sig
SECONDARY Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for GFL at Maximum Contraction as Assessed by the Investigator at Day 30	0; 88.6	<0.0001 sig
SECONDARY Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for HFL at Maximum Contraction as Assessed by the Investigator at Day 30	0; 92.0	<0.0001 sig
SECONDARY Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Investigator at Day 30	3.3; 81.3	<0.0001 sig
SECONDARY Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for GFL at Maximum Contraction as Assessed by the Subject at Day 30	2.2; 75.6	<0.0001 sig
SECONDARY Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for HFL at Maximum Contraction as Assessed by the Subject at Day 30	1.1; 77.3	<0.0001 sig
SECONDARY Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Subject at Day 30	3.3; 65.9	<0.0001 sig
SECONDARY Main Period: Global Aesthetic Improvement Scale (GAIS) at Day 30 as Assessed by the Subjects	0.08; 2.24	<0.0001 sig
SECONDARY Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 on MAS for GFL at Maximum Contraction as Assessed by the Investigator	1.1; 96.5; 96.7	<0.0001 sig
SECONDARY Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 on MAS for HFL at Maximum Contraction as Assessed by the Investigator	2.2; 96.0; 96.7	<0.0001 sig
SECONDARY Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Investigator	7.9; 89.0; 29.3	<0.0001 sig
SECONDARY Main Period: Global Aesthetic Improvement Scale (GAIS) at Day 30 as Assessed by the Investigator	0.05; 2.43; 1.99	<0.0001 sig
SECONDARY Main Period: Number of Subjects With Related Treatment-Emergent Adverse Events (TEAEs)	2; 11; 6	—
SECONDARY OLEX Period: Number of Subjects With Related TEAEs	10; 6; 3	—

Summary

The purpose of this study is to investigate the safety and efficacy of NT 201 (active ingredient: Botulinum (neuro)toxin type A, free from complexing proteins) in the combined treatment of wrinkles in the upper face (Upper Facial Lines [UFL]): Horizontal Forehead Lines [HFL], Glabellar Frown Lines [GFL], and Lateral Canthal Lines [LCL]). It is a prospective, randomized, double-blind, placebo-controlled, multicenter study with a placebo-control main period (MP) followed by an open-label extension (OLEX) period.

Eligibility Criteria

Inclusion Criteria

Outpatients (male or female) 18 years of age or older.
Horizontal forehead lines (HFL), glabellar frown lines (GFL), and symmetrical lateral canthal lines (LCL) of moderate to severe intensity at maximum contraction as assessed by the investigator and subject according to Merz Aesthetics Scales (MAS).

Exclusion Criteria

Previous treatment with botulinum neurotoxin (BoNT) of any serotype in the face within the last 12 months before injection.
Any facial cosmetic procedure within the last 12 months before baseline injection.
Previous treatment with any biodegradable filler in the face within the last 12 months before injection.
Any previous insertion of permanent material in the face (regardless of the time between previous treatment and this study).
Any medical condition that may put the subject at increased risk with exposure to NT201.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04594213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.